Study Startup
Section 2
Implementation Readiness Checklist
The checklist below identifies milestones that mark trial readiness.
Milestone | Completed |
---|---|
Recruitment plans are finalized | |
All sites identified (documentation of site commitment) | |
Methods for accurately identifying participants validated | |
All agreements for necessary subcontracts in place | |
Ethical/regulatory aspects are addressed | |
Coordinated IRB oversight in place | |
Finalized plans for informed consent or waiver of informed consent | |
Finalized data and safety monitoring plan | |
Intervention is fully developed and finalized | |
Finalized intervention (including materials and training at sites) ready for site implementation | |
Finalized protocol is IRB approved (informed consent and data collection forms, if applicable) | |
Data collection methods are adequately tested | |
Validated methods for the electronic health record information | |
Validated study surveys, interviews, or other data collection modes | |
Demonstrated quality assurance and harmonization of data elements across healthcare systems/sites | |
Statistical and data analysis methods have been adequately developed | |
Budget is realistic, feasible, and accounts for potential changes |
SECTIONS
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